Data / Medical devices / United States / Rowpar Pharmaceuticals Inc.
Rowpar Pharmaceuticals Inc.: FDA-registered device maker in Bridgewater, NJ, United States, 1 510(k) clearance
Rowpar Pharmaceuticals Inc. is registered with the FDA (registration 3030049002) in Bridgewater, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 19, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030049002
- Address
- 440 Us Highway 22 Ste 210, Bridgewater, NJ, United States, 08807
- Owner or operator
- Rowpar Pharmaceuticals Inc. (10094489)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 3, 2025
- Registered through
- 2026
- Brand names listed
- CloSYS Dry Mouth Sensitive Mouth Rinse
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Saliva, Artificial | LFD | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 19, 2025 | K250390 | CloSYS® Dry Mouth Sensitive Mouth Rinse | LFD | Substantially Equivalent | Rowpar Pharmaceuticals, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.